Balloon vs stent: new hope for heart patients without permanent metal?
NCT ID NCT04893291
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a sirolimus-coated balloon works as well as a standard drug-eluting stent for opening narrowed heart arteries. About 1,820 adults with coronary artery disease will be randomly assigned to receive either the balloon or the stent during a routine angioplasty procedure. The main goal is to see if the balloon is non-inferior to the stent in preventing artery failure at one year.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Sirolimus-coated balloon (Magic Touch) and everolimus-eluting stent
What this could lead to
If successful, this could offer a stent-free option for opening blocked heart arteries, potentially reducing long-term complications from permanent implants.
What could go wrong
This is a large but early-stage comparison; the balloon may not be as effective as the standard stent, and risks like artery re-narrowing or bleeding remain.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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1st Military Institute of Medicine
Lublin, Poland
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A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli
Palermo, Italy
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ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
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Albert Schweitzer Hospital
Dordrecht, Netherlands
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Altnagelvin Area Hospital
Londonderry, United Kingdom
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Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"
Palermo, Italy
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Azienda Ospedaliera Universitaria Integrata
Verona, Italy
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Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, Italy
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Bangladesh Specialized Hospital Lt
Dhaka, Bangladesh
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Centre Hospitalier de SaintMalo
St-Malo, France
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Clinica Polispecialistica San Carlo
Paderno Dugnano, 20037, Italy
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Clinique Louis Pasteur
Essey-lès-Nancy, France
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Clinique Saint-Hilaire
Rouen, France
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Erasmus University Medical Center
Rotterdam, Netherlands
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Fondazione Poliambulanza
Brescia, 25124, Italy
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Golden Jubilee National Hospital
Clydebank, United Kingdom
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Groupe Hospitalier de La Rochelle
La Rochelle, France
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Haga Hospital Els Borst
The Hague, Netherlands
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Heliodors Święcicki Clinical Univeristy Hospital, Ul
Poznan, Poland
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Hospital Alvaro Cunqueiro-University Hospital of Vigo
Vigo, Spain
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Hospital General Universitario de Ciudad Real (HGUCR)
Ciudad Real, Spain
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Hospital Queen Elizabeth II
Kota Kinabalu, Malaysia
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Hospital Santa Isabel R. Frei Cornélio
Ubá, Brazil
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Hospital Universitario La Paz
Madrid, Spain
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Hospital Universitario Lucus Augusti (HULA)
Lugo, Spain
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Hospital Universitario Marqués de Valdecilla (HUMV)
Santander, Spain
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Hospital Universitario de Araba
Vitoria-Gasteiz, Spain
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Hospital Universitario y Politécnico La Fe
Valencia, Spain
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
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Hospital de La Princesa
Madrid, Spain
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Hôpital Prive du Confluent, 4 Rue Éric Tabarly
Nantes, France
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INC (National Institute of Cardiology),
Rio de Janeiro, Brazil
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InCor (Heart Institute)
São Paulo, Brazil
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Institute Dante Pazzanese of Cardiology
São Paulo, Brazil
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Istituto clinico Sant'Ambrogio
Milan, Italy
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Jurong Park Medical Centre JPMC
Bandar Seri Begawan, Brunei
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Kurmitola General Hospital
Dhaka, Bangladesh
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LABAID Cardiac Hospital
Dhaka, Bangladesh
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Les Hôpitaux de Chartres, Hôpital Louis Pasteur
Le Coudray, France
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Maasstad Hospital
Rotterdam, Netherlands
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National Heart Foundation Hospital & Research Institute
Dhaka, Bangladesh
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National Institute of Cardiovascular Disease
Dhaka, Bangladesh
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OLVG Onze Lieve Vrouwe Gasthuis location East
Amsterdam, Netherlands
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Ospedale Civile Sant'Andrea
La Spezia, Italy
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Ospedale Policlinico San Martino
Genova, Italy
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Ospedale S. Antonio Abate
Trapani, Italy
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Ospedale San Giuseppe Moscati
Aversa, Italy
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Ospedale Sandro Pertini
Roma, 00157, Italy
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Policlinico Tor Vergata
Roma, Italy
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Ramathibodi Hospital, Mahidol University
Bangkok, Thailand
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St Bartholomew's Hospital
London, United Kingdom
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University Hospitals Birmingham
Birmingham, United Kingdom
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University Malaya Medical Centre (Teaching and Research Hospital)
Kuala Lumpur, Malaysia